Chronic Low Back Pain
Conditions
Brief summary
Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.
Interventions
OTHERQuestionnaires
set of questionnaires to be filled out once
Sponsors
Centre Hospitalier Valida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Diagnosis of chronic low back pain by a physician, defined as pain located in the lumbar region (between the lower edge of the sides and the gluteal fold) that is persistent or recurrent for at least 12 weeks. * Ability to complete questionnaires in French, informed consent. * Signed informed consent before any participation in the study.
Exclusion criteria
* Recent lumbar surgery (\< 6 months) or current surgical indication. * Severe neurological condition (stroke, neurodegenerative diseases, head injury, etc.), active cancer, pregnancy. * Severe psychiatric condition. * Participation in another clinical trial within the last 6 months. * Inability to understand French or to complete the questionnaires independently. * Refusal to participate. * Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) | at inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nottingham Leisure Questionnaire | at inclusion | A 30-item, self-report assessment tool primarily designed to measure leisure activity participation in adults, particularly stroke survivors, but also used for other populations. It evaluates the frequency of various social and solitary activities (indoor/outdoor) over the previous few weeks using a 3-point scale: 0 (never), 1 (occasionally), and 2 (regularly). The total score ranges from a minimum of 0 to a maximum of 60. Higher scores mean engaging more regularly in leisure practice. |
| Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) | at inclusion | A, 29-question, patient-reported survey measuring health-related quality of life across seven core domains: physical function, fatigue, pain interference, depression, anxiety, sleep disturbance, and social roles. Developed by the NIH, it includes a 0-10 pain intensity item and four questions per domain. Scores are transformed in a T-score with a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates a better outcome than average. |
| Simple Physical Activity Questionnaire (SIMPAQ) | at inclusion | A 5-item clinical tool designed to assess physical activity among populations at high risk of sedentary behaviour.T he Simple Physical Activity Questionnaire (SIMPAQ) is scored by calculating the average daily time (in hours or minutes) spent on five categories over the past week: time in bed, sedentary behavior, walking, structured exercise, and incidental activity. These five components should sum to approximately 24 hours per day, which provides a check for reporting accuracy. Time spent on physical activity is calculated by summing walking and structured exercise. The lowest score is 0 hours and the highest 24 hours. Higher scores means more time spent exercising. |
| Leisure Motivation Scale (LMS-28) | at inclusion | This scale assesses people's motivation for engaging in their leisure activities. It assesses 7 types of motivation : intrinsic motivation toward knowledge, accomplishment and stimulation, as well as external, introjected and identified regulations and amotivation. It contains 28 items (4 items for each of the 7 sub-scales) assessed on a 7-point scale. Scores for each subscale are summed to determine which motivations (e.g., intellectual, social, competence, stimulus-avoidance) drive the behavior (ranging from 4 to 28 points). The highest scoring subscale identifies the primary reason for a person's engagement in leisure activities. |
| Hospital Anxiety and Depression Scale (HADS) | at inclusion | A 14-item, self-report screening tool (7 questions for anxiety, 7 for depression) used to detect emotional distress in patients with physical health conditions. It is scored by summing responses to the 14 items , each rated 0-3. Subscales (HADS-A and HADS-D) range from 0 to 21. Scores of 0-7 are normal, 8-10 mild, 11-14 moderate, and 15-21 severe. Higher scores indicate higher distress. |
| Oswestry Disability Index (ODI) | at inclusion | A self-administered questionnaire that measures a patient's functional disability caused by low back pain. It consists of 10 items assessing daily activities (e.g., pain, lifting, walking), with scores from 0-100% representing disability levels from minimal to bedbound. |
Countries
Belgium
Outcome results
None listed